Relief and NeuroRx Conclude Enrollment in their Phase 2b/3 Trial of RLF-100(TM) for Critical COVID-19 with Respiratory Failure
Geneva, Switzerland and Radnor, Pa, USA, December 30, 2020 - RELIEF THERAPEUTICS Holding AG (SIX: RLF, OTCQB: RLFTF) ("Relief" or the "Company") and NeuroRx, Inc. today announced the conclusion of enrollment in the phase 2b/3 trial of ZYESAMI(TM) (previously RLF-100TM: aviptadil) for the treatment of Respiratory Failure in patients with Critical COVID-19 (www.clinicaltrials.gov NCT04311697). No drug-related serious adverse events have been reported as of today. Enrollment was increased from 165 patients in order to amass as large a safety database as possible. Top line data are expected in late January - early February 2021.
"With FDA's authorization and the extraordinary dedication of our twelve clinical trial sites, we were able to take a drug not formulated or administered to patients in IV form since 2005 and advance it to the clinic in ten weeks. We hope that the highly encouraging results seen in the most critically-ill COVID-19 patients treated in our expanded access program can be replicated in patients who have Critical COVID-19 without an advanced comorbidity" said Prof. Jonathan Javitt, CEO and founder of NeuroRx, Inc. "The FDA did not agree to grant EUA, as applied for in September, based upon the open-label study reported earlier, but has advised us that they remain committed to working with us in the development of our product and will promptly review the forthcoming data from this randomized trial. Until that time, available stocks of ZYESAMITM (RLF-100TM) will continue to be administered under our Expanded Access Protocol and individual patient requests under Right to Try laws."
Raghuram (Ram) Selvaraju, Chairman of the Board of Relief, said: "We congratulate NeuroRx on the successful completion of patient enrollment in this crucial pivotal clinical study and look forward to the top line results. Our fervent hope is for RLF-100TM to bring benefit to critically ill patients suffering the consequences of COVID-19 infection."
